Clinical and Histological Study of a Novel Dermal Substitute
The goal of this observational study is to compare a novel dermal substitute to a the current standard procedure in the treatment of full thickness skin defects. The main questions aim to answer are: • Is the skin elasticity treated with the novel dermal substitute better than the skin elasticity treated with the curre
| Condition(s) | Skin Transplantation |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | The goal of this observational study is to compare a novel dermal substitute to a the current standard procedure in the treatment of full thickness skin defects. The main questions aim to answer are: • Is the skin elasticity treated with the novel dermal substitute better than the skin elasticity treated with the current standard procedure Participants skin elasticity will be measured by Cutometer® MPA-580 assessment. |
| Who can participate | Inclusion Criteria: * Age: 1 to 75 years * Full-thickness skin defect qualifying for coverage with the dermal substitute NovoSorb® BTM before transplantation with a STSG: * Acute cases: burn injury, soft tissue injury, skin necrosis after purpura fulminans or similar condition * Reconstructive cases (elective surgery): e.g. scar formation after burn injury, giant congenital nevus, defect after removal of skin tumor, skin defect due to other surgical procedures * Documented medical treatment decision of covering the full-thickness skin defects with either the two-step BTM/STSG procedure or with STSG alone or by using both techniques on different wound areas * Informed consent by patients/parents or other legal representative Exclusion Criteria: * Infected wounds needing surgical procedure o |
| Ages | 1 Year to 75 Years |
| Sex | All |
| Lead sponsor | University Children's Hospital, Zurich |
| Locations | Aarau, Canton of Aargau, Switzerland; Zurich, Canton of Zurich, Switzerland; Zurich, Canton of Zurich, Switzerland; Winterthur, Winterthur, Switzerland |
| Start date | 2024-01-15 |
| NCT ID | NCT06255990 |
| Official listing | https://clinicaltrials.gov/study/NCT06255990 |